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Foscarnet Treatment of Serious CMV Retinitis Infection in Patients With Acquired Immunodeficiency Syndrome


Phase 1
13 Years
65 Years
Not Enrolling
Both
Cytomegalovirus Retinitis, HIV Infections

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Trial Information

Foscarnet Treatment of Serious CMV Retinitis Infection in Patients With Acquired Immunodeficiency Syndrome


Foscarnet is active in vitro (test tube) against herpes viruses, including CMV, by
inhibiting the virus DNA polymerases, enzymes necessary for virus replication, without
affecting cellular DNA polymerases. Opportunistic CMV disease in AIDS is usually seen as
retinitis, colitis, esophagitis, hepatitis, pancreatitis, encephalitis, or pneumonia.
Ganciclovir has been used to treat AIDS patients with CMV disease but can cause severe
neutropenia (very low neutrophil cell counts). Foscarnet does not suppress the production of
neutrophils or other leukocytes (myelosuppression) and has shown in vitro activity against
HIV.

Treatment is given for a total of 10 weeks with a 2-week induction regimen followed by
randomization to daily maintenance foscarnet for 8 weeks. If induction therapy is tolerated
without unexpected toxicity, patients are allowed to self-administer foscarnet at home via
central venous catheter and may receive up to 11 days of induction therapy by
self-administration on an outpatient basis. Foscarnet will be administered in open-label
fashion so that both investigator and patient will know the dose. Within the study, there
are 8 patients who upon entering the 2nd week of maintenance foscarnet therapy are treated
with zidovudine (AZT).

Inclusion Criteria


Exclusion Criteria

Concurrent Medication:

Excluded:

- Acyclovir.

- Zidovudine (AZT).

- Any potentially nephrotoxic agent, especially aminoglycosides, pentamidine, or
amphotericin B.

Prior Medication:

Excluded:

- Ganciclovir.

- Foscarnet.

- Excluded within 7 days of study entry:

- Any potentially nephrotoxic agent.

- Excluded within 14 days of study entry:

- Cytomegalovirus hyperimmune globulin in therapeutic doses.

- Immunomodulators.

- Biologic response modifiers.

- Investigational agents.

- Amphotericin B maintenance for a systemic mycosis.

Known allergy to foscarnet.

Active AIDS-defining opportunistic infection other than cytomegalovirus (CMV) including
systemic mycosis, pulmonary or neurologic impairment (comatose).

Patient must be diagnosed as having:

- AIDS CDC Group IV.C.

- Cytomegalovirus (CMV) retinitis as identified by its characteristic ophthalmoscopic
appearance and verified by fundus photography.

- One pending culture for CMV from blood and urine prior to study entry.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacokinetics Study, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Jacobson M

Investigator Role:

Study Chair

Authority:

United States: Federal Government

Study ID:

ACTG 015

NCT ID:

NCT00000726

Start Date:

Completion Date:

February 1992

Related Keywords:

  • Cytomegalovirus Retinitis
  • HIV Infections
  • Retinitis
  • AIDS-Related Opportunistic Infections
  • Foscarnet
  • Cytomegalovirus Infections
  • Acquired Immunodeficiency Syndrome
  • Antiviral Agents
  • Acquired Immunodeficiency Syndrome
  • HIV Infections
  • Immunologic Deficiency Syndromes
  • Retinitis
  • Cytomegalovirus Retinitis

Name

Location

Mem Sloan - Kettering Cancer CtrNew York, New York  10021
Los Angeles County - USC Med CtrLos Angeles, California  90033
UCLA CARE CtrLos Angeles, California  90095
San Francisco AIDS Clinic / San Francisco Gen HospSan Francisco, California  941102859
USC School of Medicine / Norris Cancer HospLos Angeles, California  90033